Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Dr. Richard Schlenk, University of Ulm

ClinicalTrials.gov Identifier:

NCT00151242

First received: September 6, 2005

Last updated: February 14, 2013

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

February 14, 2013

Start Date ^ICMJE

July 2004

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Complete remission (CR)-rate after induction therapy [ Time Frame: after the second induction cycle ] [ Designated as safety issue: No ]
Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy [ Time Frame: One year after consolidation therapy ] [ Designated as safety issue: No ]
Event-free survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

CR-rate after induction therapy

Change History

Complete list of historical versions of study NCT00151242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs [ Time Frame: during therapy ] [ Designated as safety issue: No ]
Cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]
Cumulative incidence of death [ Time Frame: two years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle [ Time Frame: during consolidation therapy ] [ Designated as safety issue: Yes ]
Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle [ Time Frame: during consolidation therapy ] [ Designated as safety issue: No ]
Hematologic and non-hematologic toxicity after consolidation therapy with high-dose cytarabine considering the different consolidation schemes (day 1-3-5 versus day 1-2-3) [ Time Frame: during consolidation therapy ] [ Designated as safety issue: Yes ]
Days in hospital after each consolidation cycle [ Time Frame: after consolidation therapy ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs
cumulative incidence of relapse
cumulative incidence of death
Overall survival
Event-free survival
Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle Days in hospital after each consolidation cycle
Timely sequence of the Pegfilgrastim-concentration in correlation to the absolute neutrophile counts after each consolidation cycle

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Official Title ^ICMJE

Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Brief Summary

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

Detailed Description

First Induction Therapy:

Cytarabine 100 mg/m² cont. i.v. days 1-7
Idarubicin 12 mg/m² i.v. days 1,3,5
Etoposide 100 mg/m² i.v. days 1-3
± ATRA 45 mg/m² p.o. days 6-8
ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

Cytarabine 100 mg/m² cont. i.v. days 1-7
Idarubicin 12 mg/m² i.v. days 1 and 3
Etoposide 100 mg/m² i.v. days 1-3
± ATRA 45 mg/m² p.o. days 6-8
ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (<= ID 336)

Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
± ATRA 15 mg/m² p.o. Tag 6-21
Pegfilgrastim 6 mg s.c day 10

cohort 2 (> ID 336)

Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
± ATRA 15 mg/m² p.o. Tag 4-21
Pegfilgrastim 6 mg s.c day 8

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myeloid Leukemia

Intervention ^ICMJE

Drug: Cytarabine
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
Drug: Idarubicin
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
Drug: Etoposide
100mg/m² i.v. day 1-3 (induction therapy)
Drug: All-trans retinoic acid
45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
Drug: Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)

Other Name: Neulasta

Study Arm (s)

Active Comparator: 1
Interventions:
- Drug: Cytarabine
- Drug: Idarubicin
- Drug: Etoposide
- Drug: Pegfilgrastim
Experimental: 2
Interventions:
- Drug: Cytarabine
- Drug: Idarubicin
- Drug: Etoposide
- Drug: All-trans retinoic acid
- Drug: Pegfilgrastim

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

920

Estimated Completion Date

August 2013

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia [APL])
Ages 18-60 years
Written informed consent of each patient at study entry.
Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories

Exclusion Criteria:

Bleeding independent of the AML
Acute promyelocytic leukemia
Uncontrollable infection
Participation in a concurrent clinical study
Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
No consent for registration, storage and processing of the individual disease-characteristics and course.
Performance status WHO > 2
Pregnancy

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT Number ^ICMJE

NCT00151242

Other Study ID Numbers ^ICMJE

AMLSG07-04

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Richard Schlenk, University of Ulm

Study Sponsor ^ICMJE

University of Ulm

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard F Schlenk, Dr.

Department of Internal Medicine III, University of Ulm

Information Provided By

University of Ulm

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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